Attachment 7 - Informed consent

Research Informed Consent

Improving Quality through Health IT: Testing the Feasibility and Assessing the Impact of Using Existing Health IT Infrastructure for Better Care Delivery

Principal Investigator (PI): Romana Hasnain-Wynia, PhD

Northwestern University, Feinberg school of Medicine

(312) 503-5509

Funding Source: Agency for Healthcare Research and Quality (AHRQ)

Purpose

The Alliance of Chicago in partnership with Health Research and Educational Trust (HRET), an affiliate of the American Hospital Association, is conducting a study on how the use of health IT can improve care delivery and outcomes by documenting and facilitating the use of lab order and results information. You are being asked to participate in an interview as part of this study because you are knowledgeable about lab information processes at your center. This study is being conducted at Howard Brown Health Center and Heartland Health Outreach. Please read this form and ask any questions you may have before agreeing to be in the study.

In this research study, the investigators are interested in how health IT plays a role in lab ordering and results review and opportunities to improve compliance with evidence-based guidelines and reduce the numbers of duplicate lab tests, “lost” results, and results lacking follow-up.

Study Procedures

If you agree to take part in this research study, you will be asked to participate in a 60-90 minute interview with a study investigator. A number of other staff members at your center will also be asked to participate in separate interviews. Your collective responses to the questions will be provided to the research team at the HRET.

Your participation in this survey is entirely voluntary. You may decline to participate at any time without penalty. However, your participation will provide very important information for the project.

Benefits

The possible benefits to you for taking part in this research study are ideas for improvement of lab processes at your center. Ideally the study will determine ways to increase compliance with evidenced-based lab protocols, reduce duplicate lab tests, and reduce abnormal lab results lacking follow up. In addition, your center will be provided with $2,500 as compensation for staff time.

Risks

There are no known risks at this time to participation in this study.

Study Costs

Participation in this study will be of no cost to you, other than your time.

Compensation

You will not be paid for taking part in this study.

Confidentiality

This survey does not ask for personal information about you – only questions about common practices and procedures in the health center. Information that identifies you personally will not be released. Data will be kept confidentially at HRET or by a study team member. When the results of this research are published or discussed in conferences, no information will be included that would reveal your identity.

Voluntary Participation/Withdrawal

Taking part in this study is voluntary. You have the right to choose not to take part in this study. You are free to only answer questions that you want to answer. You are free to withdraw from participation in this study at any time. Your decisions will not change any present or future relationship with your center or Alliance of Chicago, or other services you are entitled to receive.

Questions

If you have any questions about this study now or in the future, you may contact Principal Investigator (above) or Ann Scheck McAlearney, a member of the research team at (xxx) xxx-xxxx.

Consent to Participate in a Research Study

To voluntarily agree to take part in this study, you must sign on the line below. If you choose to take part in this study you may withdraw at any time. You are not giving up any of your legal rights by signing this form. Your signature below indicates that you have read, or had read to you, this entire consent form, including the risks and benefits, and have had all of your questions answered. You will be given a copy of this consent form.

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Signature of participant Date

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Printed name of participant

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Signature of person obtaining consent Date

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Printed name of person obtaining consent Time